Clinical Utility of Colosafe®Is Once Again Proved Valuable!

creativebio 2021-03-17

Recently a clinical study called "A novel stool-based SDC2 DNA methylation test is more robust than FIT and plasma CEA in detecting colorectal neoplasia in China" was published on American Journal of Translational Medicine. The study compared the detection performance of Colosafe®, FIT and plasma CEA. The result evidently revealed the value and advantage of Colosafe® in clinical application.



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BACKGROUND: Recent studies have shown that aberrant methylation of Syndecan-2 (SDC2) can be detected in stool samples from patients with colorectal cancer (CRC) and advanced adenoma (AA). This study aims to evaluate both the effectiveness and accuracy of a stool DNA (sDNA) test of methylated SDC2 in detecting CRC and AA in comparison to a fecal immunochemistry test (FIT) and plasma carcinoembryonic antigen (CEA). METHODS: The study enrolled 120 participants who were either diagnosed with CRC and AA or were CRC- or AA-negative according to colonoscopy. Stool samples for each participant were collected and subjected to both FIT and the sDNA test for SDC2 methylation. Meanwhile, peripheral blood was drawn to assess plasma CEA level. Analytical performance of these three detection methods was compared in terms of sensitivity and specificity. Furthermore, Spearman correlation was performed to evaluate possible correlation between SDC2 methylation and clinical characteristics in CRC patients. RESULTS: The sensitivity of the sDNA test in detecting CRC was 90.7%, significantly higher than both FIT (58.1%) and plasma CEA (20.9%). The detection rate of the sDNA test for AA was also respectable at 52.7%, dramatically better than FIT (9.1%) and plasma CEA (3.6%). The sDNA test was also particularly robust for stage I/II CRC at 87% sensitivity. Moreover, it could detect a significant number of colonic carcinomas in situ as well as high-grade intraepithelial neoplasia, besting FIT and CEA by a large margin (11/13 vs. 3/13 vs. 1/13). For both SDC2 testing and FIT, the specificity was 86.4%, lower than the 90.9% specificity observed for plasma CEA. Interestingly, we found that SDC2 methylation status was positively correlated with tumor location, TNM staging, and size, but inversely correlated with age at diagnosis. CONCLUSIONS: Single-target SDC2 methylation testing is a more sensitive detection strategy for CRC and AA than conventional approaches such as FIT and plasma CEA in China. [Am J Transl Med 2020. 5(1):37-50].

Keywords: Colorectal neoplasia, SDC2, Stool DNA, Gene methylation, Sensitivity

(Manuscript received July 5, 2020, accepted July 28, 2020; published online January 30, 2021)

All samples used in this study were from Shanghai Songjiang District Central Hospital. The scientific evidence from the paper once again verified superior performance of Colosafe® in clinical practice. Colosafe® has been promoted nationwide in China. The clinical data throughout the past three years from top hospitals in varied regions has demonstrated its consistency and accuracy in clinical practice. It has become a major screening method for colorectal cancer. It is the first NMPA-approved stool DNA test kit for colorectal cancer in China and has been recommended in the “Expert Consensus on Early Screening Protocol for Colorectal Cancer in China (2019 in Shanghai)” as one of the first-line options in population screening of colorectal cancer in addition to aiding clinical diagnosis of the malignant disease.

Over the years, CreativeBio has been striving to create every authentic product with innovative research and rigorous testing. In October, 2020, a paper on the outcome of a clinical trial of Colosafe sponsored by CreativeBio was published on Clinical Epigenetics titled “Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study”. By far, Colosafe® is the only stool-based testing product in China with peer-reviewed clinical studies published in international top-tiered journals, demonstrating the company’s stringent and scientific approach in developing products for making a healthier world.

There is an old saying in Chinese that “a long road tests a horse's stamina”, meaning in our case, that time will reveal the quality of our product and the character of our company. Early screening of colorectal cancer in China is still a nascent industry. CreativeBio is a trailblazer constantly in actions to develop innovative and advanced products to ultimately realize its lofty goal of “Human Health, My Mission”.


1. Wang X, Xu P, Shen H, et al. A novel stool-based SDC2 DNA methylation test is more robust than FIT and plasma CEA in detecting colorectal neoplasia in China. Am J of Translational Medicine. 2021; 5(1):37-50.
2. Wang, J., Liu, S., Wang, H. et al. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics 2020;12(1): 162. doi: 10.1186/s13148-020-00954-x.